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Using Decision Analysis to Enhance Decision-Making Regarding Prostate Cancer Screening

Sponsor
Case Comprehensive Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT03387527
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
9
Actual Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate a new counseling tool for patients deciding whether or not to undergo prostate cancer screening. This screening decision aid is a computer program that provides individual patients estimates of their risks of prostate cancer diagnosis, prostate cancer related death, or death from any cause. The researchers are evaluating whether or not patients find this screening decision aid helpful. As part of this study, participants will be asked for their response on questionnaires.

If patients find the screening decision aid helpful, the researchers will make it available at other clinic locations.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Prostate cancer decision aid
 N/A

Detailed Description

To conduct a feasibility study on implementing the computer-based screening decision aid for prostate cancer screening in a primary care setting during a 60-minute interview. To aid in informed decision making, the screening decision aid will include a graphical representation of predicted probabilities of prostate cancer diagnosis, prostate cancer-specific mortality, death from competing causes based on a man's unique demographic information. The study team will provide standardized counseling followed by individualized counseling with the screening decision aid. It will assess the quality of the decision making process (patient feels knowledgeable, informed of the risks/benefits, feels clear about their values, is involved in the decision), and quality of the decision.

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Using Decision Analysis to Enhance Decision-Making Regarding Prostate Cancer Screening
Actual Study Start Date :
Feb 1, 2018
Actual Primary Completion Date :
Oct 3, 2018
Actual Study Completion Date :
Nov 3, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Prostate Cancer Decision Aid

The research intervention will be exposure to the screening decision aid. Patients will receive standardized counseling including population based risks and benefits of prostate cancer screening. Then, patients will be given opportunity to review the screening decision aid prior to offering a decision on whether or not to undergo prostate cancer screening. The patient decision aid will be a computer application that generates predicted risks associated with prostate cancer.

Behavioral: Prostate cancer decision aid
Patients will undergo standardized counseling and individualized counseling with the screening decision aid. The screening decision aid is a computer program that provides individual patients estimates of their risks of prostate cancer diagnosis, prostate cancer related death, or death from any cause
Other Names:
  • screening decision aid

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of initial interviews completed in 60 minutes [60 minutes from beginning of interview]

      To be considered feasible in a busy clinical setting, researchers anticipate 80% of the initial interviews to be completed within the allotted 60-minute interview time.

    Secondary Outcome Measures

    1. Health Literacy [1 month after clinical visit]

      Five item scale measuring attitudes towards screening

    2. Patient decisional control preferences [1 month after clinical visit]

      4 item scale where lower scores indicate more positive outcomes from screening

    3. Decisional conflict Scale [1 month after clinical visit]

      16 item scale ranging in a score from 0-4 where higher scores indicate more disagreement

    4. Multidimensional measure of informed choice [1 month after clinical visit]

      10 item true/false scale

    5. Decisional regret scale [1 month after clinical visit]

      5 item questionnaire using 5 point Likert scales where higher scores indicate more disagreement

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years to 69 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Life expectancy > 10 years

    • Ability to read English

    Exclusion Criteria:

    • Personal history of prostate cancer

    • Personal history of prostate biopsy or prostate surgery

    • Prior prostate specific antigen screening in the past year leading up to their scheduled clinic visit

    • Cognitive impairment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center Cleveland Ohio United States 44195

    Sponsors and Collaborators

    • Case Comprehensive Cancer Center

    Investigators

    • Principal Investigator: Michael A Brooks, MD, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Case Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT03387527
    Other Study ID Numbers:
    • CASE7817
    First Posted:
    Jan 2, 2018
    Last Update Posted:
    Oct 24, 2019
    Last Verified:
    Oct 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Case Comprehensive Cancer Center
    Decision Aid
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Oct 24, 2019